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510(k) K182480

Device
Earlens Contact Hearing Aid
Applicant
Earlens Corporation
510(k) number
K182480
Product code
PLK  
Decision
Substantially Equivalent (SESE)
Decision date
2019-01-25
Date received
2018-09-10
Regulation
874.3315
Classification name
Tympanic Membrane Direct Contact Hearing Aid
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Judith A. Brimacombe
Address
4045 Campbell Ave. Menlo Park CA US 94025 94025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153634Wireless Earlens Light Driven Hearing AidEarlens Corporation2016-04-06
DEN150002EarLens Contact Hearing DeviceEarlens Corporation2015-09-29

Legacy Summary#

summary

FDA Review#

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